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CARAT: Canagliflozin vs. Placebo for Post Bariatric Patients With Persistent Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912455
Recruitment Status : Terminated (Study was terminated due to difficulty with reaching enrollment goals)
First Posted : September 23, 2016
Results First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Sangeeta Kashyap, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Obesity
Interventions Drug: canagliflozin
Drug: Placebo (for canagliflozin)
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 11).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =5).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Period Title: Overall Study
Started 11 5
Completed 9 2
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             0             1
Lack of Efficacy             0             1
Lost to Follow-up             2             1
Arm/Group Title Study Drug (Canagliflozin) Placebo Total
Hide Arm/Group Description

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily.

canagliflozin: encapsulated (gelatin capsule).

Drug: Placebo (for canagliflozin)

encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Total of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants 5 participants 16 participants
58
(38 to 75)
44.0
(34.0 to 59.0)
54.0
(34.0 to 75.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
7
  63.6%
4
  80.0%
11
  68.8%
Male
4
  36.4%
1
  20.0%
5
  31.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 5 participants 16 participants
11 5 16
BMI  
Median (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 11 participants 5 participants 16 participants
39.6
(28.6 to 49.4)
37.9
(31.9 to 44.7)
39.2
(28.6 to 49.4)
Height (m)  
Median (Full Range)
Unit of measure:  Meters
Number Analyzed 11 participants 5 participants 16 participants
1.7
(1.5 to 1.7)
1.7
(1.6 to 1.9)
1.7
(1.5 to 1.9)
Weight (kg)  
Median (Full Range)
Unit of measure:  Kg
Number Analyzed 11 participants 5 participants 16 participants
108.6
(78.3 to 132.9)
117.5
(86.0 to 133.7)
108.9
(78.3 to 133.7)
Hemoglobin A1c (%)  
Median (Full Range)
Unit of measure:  Percent
Number Analyzed 11 participants 5 participants 16 participants
7.2
(6.5 to 8.3)
8.2
(6.9 to 10.0)
7.4
(6.5 to 10.0)
Fasting glucose (mg/dL)  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 11 participants 5 participants 16 participants
163.0
(105.0 to 204.0)
164.0
(116.0 to 239.0)
163.5
(105.0 to 239.0)
Diastolic blood pressure (mm/Hg)  
Median (Full Range)
Unit of measure:  mmHg
Number Analyzed 11 participants 5 participants 16 participants
73.0
(52.0 to 87.0)
77.0
(51.0 to 86.0)
76.5
(51.0 to 87.0)
Systolic blood pressure (mm/Hg)  
Median (Full Range)
Unit of measure:  mmHg
Number Analyzed 11 participants 5 participants 16 participants
137.0
(106.0 to 148.0)
133.0
(117.0 to 141.0)
134.5
(106.0 to 148.0)
Uric acid (mg/dL)  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 11 participants 5 participants 16 participants
4.9
(2.9 to 7.9)
3.9
(3.3 to 5.1)
4.3
(2.9 to 7.9)
Total cholesterol (mg/dL)  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 11 participants 5 participants 16 participants
160.0
(112.0 to 257.0)
167.0
(135.0 to 202.0)
162.0
(112.0 to 257.0)
Triglycerides (mg/dL)  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 11 participants 5 participants 16 participants
130.0
(59.0 to 224.0)
107.0
(62.0 to 121.0)
109.5
(59.0 to 224.0)
LDL (mg/dL)  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 11 participants 5 participants 16 participants
87.0
(31.0 to 175.0)
108.0
(67.0 to 120.0)
92.0
(31.0 to 175.0)
HDL (mg/dL)  
Median (Full Range)
Unit of measure:  mg/dL
Number Analyzed 11 participants 5 participants 16 participants
47.0
(28.0 to 81.0)
51.0
(29.0 to 60.0)
49.0
(28.0 to 81.0)
Body fat %  
Median (Full Range)
Unit of measure:  Percentage of body fat
Number Analyzed 11 participants 5 participants 16 participants
49.3
(30.5 to 55.3)
44.1
(29.4 to 51.0)
48.6
(29.4 to 55.3)
Lean mass %  
Median (Full Range)
Unit of measure:  Percentage of lean mass
Number Analyzed 11 participants 5 participants 16 participants
50.7
(44.7 to 69.5)
55.9
(49.0 to 70.6)
51.5
(44.7 to 70.6)
Truncal fat  
Median (Full Range)
Unit of measure:  Percentage of truncal fat
Number Analyzed 11 participants 5 participants 16 participants
53.5
(36.8 to 55.3)
47.8
(34.9 to 54.0)
50.9
(34.9 to 55.3)
Android fat  
Median (Full Range)
Unit of measure:  Percentage of android fat
Number Analyzed 11 participants 5 participants 16 participants
55.6
(41.1 to 58.6)
51.3
(38.0 to 56.3)
53.9
(38.0 to 58.6)
Gynoid fat  
Median (Full Range)
Unit of measure:  Percentage of gynoid fat
Number Analyzed 11 participants 5 participants 16 participants
48.1
(27.5 to 55.3)
47.3
(30.1 to 55.6)
47.7
(27.5 to 55.6)
Spine BMD  
Median (Full Range)
Unit of measure:  G/cm^2
Number Analyzed 11 participants 5 participants 16 participants
1.2
(1.03 to 1.8)
1.3
(1.05 to 1.3)
1.2
(1.03 to 1.8)
Leg BMD  
Median (Full Range)
Unit of measure:  G/cm^2
Number Analyzed 11 participants 5 participants 16 participants
1.2
(1.07 to 1.9)
1.2
(1.05 to 1.4)
1.2
(1.05 to 1.9)
HMW adiponectin  
Median (Full Range)
Unit of measure:  ug/mL
Number Analyzed 11 participants 5 participants 16 participants
2.9
(0.8 to 10)
3.3
(1.6 to 7)
3.1
(0.8 to 10)
Adiponectin  
Median (Full Range)
Unit of measure:  ug/mL
Number Analyzed 11 participants 5 participants 16 participants
4.2
(1.5 to 17)
5
(3 to 10)
4.6
(1.5 to 17)
Leptin  
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 11 participants 5 participants 16 participants
28
(5.3 to 87)
29
(4.7 to 117)
28.5
(4.7 to 117)
CRP  
Median (Full Range)
Unit of measure:  mg/L
Number Analyzed 11 participants 5 participants 16 participants
4.1
(1.00 to 44.5)
0.45
(0.20 to 3.8)
3.7
(0.20 to 44.5)
1.Primary Outcome
Title The Change in Hemoglobin A1c From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery
Hide Description Actual change at six months versus baseline in hemoglobin A1c value (%)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: percentage
-0.31
(-0.72 to 0.10)
0.11
(-0.71 to 0.93)
2.Secondary Outcome
Title Change in Fasting Glucose From Randomization
Hide Description The change in fasting glucose from randomization following the 6 month administration of canagliflozin vs. placebo in patients with type 2 diabetes post-bariatric surgery.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-32.90
(-56.02 to -9.79)
-44.61
(-102.39 to 13.17)
3.Secondary Outcome
Title The Change in Body Weight From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description Change in body weight at six months compared to baseline
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: kilograms
-3.77
(-6.33 to -1.22)
6.33
(-1.50 to 14.16)
4.Secondary Outcome
Title The Change in Total Cholesterol From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-0.87
(-26.59 to 24.85)
3.69
(-37.53 to 44.92)
5.Secondary Outcome
Title The Change in Diastolic Blood Pressure From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery
Hide Description Change in diastolic blood pressure at six months compared to baseline
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: mmHg
-1.18
(-6.62 to 4.26)
2.95
(-13.69 to 19.60)
6.Secondary Outcome
Title The Change in Adiponectin Levels From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description Change in adiponectin levels at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: ug/mL
0.7
(-2.2 to 5.7)
-3.4
(-9.3 to 2.5)
7.Secondary Outcome
Title The Change in Leptin Levels From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description Change in leptin levels at 6 months compared to baseline
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: ng/mL
-8.1
(-35.1 to 18.9)
-11
(-93.1 to 71.1)
8.Secondary Outcome
Title The Change in C-reactive Protein Levels From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description Change in CRP levels at 6 months compared to baseline
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: mg/L
-5.35
(-13.81 to 3.12)
3.34
(-0.76 to 7.44)
9.Secondary Outcome
Title The Number of Symptomatic Hypoglycemia Episodes From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description Number of participants who reported hypoglycemia from each group (at a frequency of 1 episode)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
2 0
10.Secondary Outcome
Title The Change in Body Fat From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery.
Hide Description Change in percent body fat as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: percent change
-1.82
(-3.83 to 0.20)
2.65
(-1.21 to 6.51)
11.Secondary Outcome
Title The Change in Systolic Blood Pressure From Randomization Following the 6 Month Administration of Canagliflozin vs. Placebo in Patients With Type 2 Diabetes Post-bariatric Surgery
Hide Description Change in systolic blood pressure at 6 months compared to baseline
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: mmHg
4.62
(-7.10 to 16.34)
12.63
(-5.02 to 30.28)
12.Secondary Outcome
Title Change in Percentage of Lean Mass
Hide Description Change in percentage of lean body mass as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: percent change
1.82
(-0.20 to 3.83)
-2.65
(-6.51 to 1.21)
13.Secondary Outcome
Title Change in Percentage of Truncal Fat
Hide Description Change in percentage of truncal fat as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: percent change
-2.67
(-5.19 to -0.16)
2.74
(-0.14 to 5.63)
14.Secondary Outcome
Title Change in Percentage of Android Fat
Hide Description Change in percentage of android fat as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: percent change
-3.00
(-5.67 to -0.32)
3.33
(0.23 to 6.43)
15.Secondary Outcome
Title Change in Percentage of Gynoid Fat
Hide Description Change in percentage of gynoid fat as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: percent change
-1.69
(-3.65 to 0.28)
2.17
(-2.26 to 6.59)
16.Secondary Outcome
Title Change in Spine Bone Mineral Density
Hide Description Change in spine bone marrow density as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: grams per square centimeter
-0.02
(-0.07 to 0.03)
0.14
(-0.11 to 0.40)
17.Secondary Outcome
Title Change in Leg Bone Mineral Density
Hide Description Change in leg bone marrow density as measured by DEXA scan at 6 months compared to randomization
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description:

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

Overall Number of Participants Analyzed 11 5
Mean (95% Confidence Interval)
Unit of Measure: grams per square centimeter
0.01
(-0.03 to 0.05)
-0.04
(-0.37 to 0.28)
Time Frame Adverse events were collected over a period of 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Drug (Canagliflozin) Placebo
Hide Arm/Group Description

Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).

Subjects randomized to placebo will be assigned a six month course of one placebo pill daily (n =12).

Placebo (for canagliflozin): encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.

All-Cause Mortality
Study Drug (Canagliflozin) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Study Drug (Canagliflozin) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Drug (Canagliflozin) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/11 (63.64%)      3/5 (60.00%)    
Gastrointestinal disorders     
Constipation *  1/11 (9.09%)  1 0/5 (0.00%)  0
Nausea *  1/11 (9.09%)  1 0/5 (0.00%)  0
Investigations     
Increased hunger *  0/11 (0.00%)  0 1/5 (20.00%)  1
Metabolism and nutrition disorders     
Hypoglycemia *  2/11 (18.18%)  2 0/5 (0.00%)  0
Hyperglycemia *  5/11 (45.45%)  8 1/5 (20.00%)  2
Dehydration *  2/11 (18.18%)  3 0/5 (0.00%)  0
Increased thirst *  5/11 (45.45%)  6 2/5 (40.00%)  2
Increased urination *  5/11 (45.45%)  6 2/5 (40.00%)  2
Nervous system disorders     
Lightheadedness * [1]  2/11 (18.18%)  2 0/5 (0.00%)  0
Syncope *  0/11 (0.00%)  0 1/5 (20.00%)  1
Renal and urinary disorders     
Urinary tract infection *  1/11 (9.09%)  1 1/5 (20.00%)  1
Genital yeast infection *  2/11 (18.18%)  2 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Vertigo/Dizziness
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Dr. Sangeeta Kashyap
Organization: Cleveland Clinic
Phone: (216) 445-2679
EMail: kashyas@ccf.org
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Responsible Party: Sangeeta Kashyap, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02912455    
Other Study ID Numbers: 16-574
First Submitted: August 24, 2016
First Posted: September 23, 2016
Results First Submitted: November 12, 2019
Results First Posted: June 30, 2020
Last Update Posted: June 30, 2020